Oral Replacement therapy in adrenocortical insufficiency
Adult: As cortisone acetate: 12.5-37.5 mg daily in divided doses. Child: As cortisone acetate: 5-25 mg daily in divided doses.
Oral Allergic and inflammatory disorders
Adult: As cortisone acetate: Usual range: Initially, 25-300 mg daily. After satisfactory initial response is achieved, decrease dose in small decrements to the lowest dosage that maintains an adequate clinical response. Dosage is individualised and adjusted according to the disease being treated and patient response. Refer to the disease-specific product guidelines for detailed dosage recommendations.
Should be taken with food.
Systemic fungal or viral infections; acute bacterial infections unless treated with specific anti-infective. Concomitant use with live vaccines (particularly immunosuppressive doses).
Patient with hypertension, heart failure, and recent MI; thromboembolic disorders, gastrointestinal disease (e.g. active or latent peptic ulcer, non-specific ulcerative colitis, diverticulitis, fresh intestinal anastomoses), diabetes mellitus, thyroid disease (e.g. hypothyroidism), cirrhosis, uraemia, epilepsy or history of seizure disorders, history of severe affective disorders (particularly steroid psychosis), emotional instability, previous steroid myopathy, osteoporosis or at risk of osteoporosis (e.g. postmenopausal women), myasthenia gravis, systemic sclerosis, ocular disease (e.g. cataract, glaucoma, history of ocular herpes simplex), history of tuberculosis. Patient subjected to stress conditions (e.g. trauma, surgery, infection). Avoid abrupt withdrawal. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Significant: Adrenal suppression (e.g. hypercortisolism, suppression of hypothalamic-pituitary-adrenal [HPA] axis), immunosuppression, Kaposi sarcoma (prolonged use), acute myopathy, left ventricular free wall rupture, osteoporosis, growth suppression (in children), posterior subscapular cataract, open-angle glaucoma, increased intraocular pressure, central serous chorioretinopathy, corneal perforation, psychiatric disturbances (e.g. insomnia, euphoria, mood swings, personality changes, severe depression, frank psychotic manifestations), seizures; withdrawal symptoms. Rarely, anaphylactoid reactions. Blood and lymphatic system disorders: Leucocytosis. Eye disorders: Corneal or scleral thinning, exophthalmos. Gastrointestinal disorders: Dyspepsia, nausea, vomiting, abdominal distension, acute pancreatitis, oesophageal candidiasis; peptic ulceration with perforation and haemorrhage. General disorders and administration site conditions: Malaise, impaired wound healing. Investigations: Weight gain, negative nitrogen balance. Metabolism and nutrition disorders: Increased appetite, Na and water retention, K loss, Cushingoid facies, diabetes mellitus, hypokalaemic alkalosis, impaired carbohydrate tolerance. Musculoskeletal and connective tissue disorders: Arthralgia, avascular osteonecrosis, tendon rupture, vertebral and long bone fracture. Nervous system disorders: Headache. Psychiatric disorders: Nervousness. Reproductive system and breast disorders: Menstrual irregularity, amenorrhoea. Skin and subcutaneous tissue disorders: Hirsutism, acne, skin atrophy, ecchymoses, erythema, bruising, striae, telangiectasia, petechiae, increased sweating. Vascular disorders: Hypertension, thromboembolism. Potentially Fatal: Acute adrenal insufficiency.
Monitor blood pressure, blood glucose (in diabetics), electrolytes, bone mineral density, growth in children. Perform eye examination periodically (prolonged use). Assess for signs and symptoms of hypercortisolism, HPA axis suppression, infection, and ocular changes.
Symptoms: Nausea, vomiting, hypoglycaemia, Na and water retention, and occasional gastrointestinal bleeding. Management: Symptomatic and supportive treatment. May prevent gastrointestinal bleeding by giving 200-400 mg IV cimetidine 6 hourly or 50 mg IV ranitidine 6 hourly.
Effects may be reduced by barbiturates, phenytoin, rifampicin and ephedrine due to enhanced metabolism. May antagonise the hypotensive and hypoglycaemic effects of antihypertensives and oral antidiabetics, respectively. May increase risk of hypokalaemia with K-depleting diuretics (e.g. thiazides), furosemide, carbenoxolone, amphotericin B. May enhance or reduce response to anticoagulants. May increase the serum levels and risk of toxicity of salicylates if cortisone is withdrawn. Metabolism may be reduced by oestrogens. May increase risk of methotrexate toxicity. Potentially Fatal: May diminish the therapeutic effects of live vaccines.
Increased risk of gastrointestinal ulceration or haemorrhage with alcohol.
Wheal and flare reactions to skin test antigens may be suppressed. May cause false-negative result in nitroblue-tetrazolinium tests for bacterial infections.
Description: Cortisone, a corticosteroid secreted by the adrenal cortex, exhibits glucocorticoid and some mineralocorticoid activity. It decreases inflammation by inhibiting the migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. Pharmacokinetics: Absorption: Readily absorbed from the gastrointestinal tract. Bioavailability: 43.7% (range: 20-95%). Time to peak plasma concentration: Approx 2 hours. Distribution: Crosses the placenta. Distributed into the skin, muscles, liver, intestines and kidneys. Plasma protein binding: >90%. Metabolism: Rapidly metabolised in the liver via reduction by 11-β-hydroxy-dehydrogenase to its active metabolite, hydrocortisone (cortisol). Excretion: Via urine and faeces. Elimination half-life: Approx 0.5 hours.
Store between 20-25°C. Protect from light and moisture.
H02AB10 - cortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
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